SDS requirements

Regulation No. 453/2010 revised Annex II of REACH and introduced new requirements for SDSs, the most important being that all classification details and label elements for both substances and mixtures are provided in section 2. Other requirements are with regard to format and information.

All SDSs currently on the market must comply with Annex I of Reg. No. 453/2010.

 

For substances:

All substances placed on the market must be classified according to the CLP Regulation (effective since 1st Dec 2010). Between 1st December 2010 and 1st June 2015, SDSs for substances prepared in accordance with Annex I of Reg. No. 453/2010 must include the classification details according to both CLP and the Dangerous Substances Directive 67/548/EEC (CPL).

The following details must be provided in Section 2 from 1st December 2010 until 1st June 2015:

 

Subsection 2.1 - Classification

  • Classification according to CLP (Regulation (EC) No 1272/2008)
  • Classification according to Directive 67/548/EEC
  • The most important adverse physical properties, human health and environmental effects in a way so as to allow non-experts to identify the hazards of the substance.

 

Subsection 2.2 - Label elements

The following elements appearing on the label according to CLP must be provided:

  • Graphical reproduction of the full hazard pictogram(s) in black and white (or colour)
  • Signal word
  • Hazard statement(s) and precautionary statement(s)

 

Subsection 2.3 - Other Hazards

Details to be provided on hazards which do not result in classification but may contribute to the overall hazard of the substance.

An example of how the classification and labelling details may be laid out for substances within section 2 from 1st December 2010 to 1st June 2015 is as follows:

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For mixtures:

  • Mixtures can continue to be classified according to the Dangerous Preparations Directive 1999/45/EC (CPL) until the 1st June 2015, after which time they must be classified according to CLP only. All SDSs for mixtures must be prepared according to Reg. No. 453/2010 and must include the classification details according to the Dangerous Preparations Directive 1999/45/EC.
  • A derogation applies for mixtures already placed on the market (i.e. “on the shelves”) before 1st June 2015 and not required to be re-labelled and re-packaged until 1st June 2017. The SDS does not need to be replaced with a SDS according to Annex II of Reg. No. 453/2010 until 1st June 2017 (unless an update in accordance with Art. 31(9) of REACH is required).

Note: Mixture suppliers can choose to implement CLP earlier than 1st June 2015 if they wish. In this case, they must provide the classification details of the mixture according to both CLP and the CPL.

The following outlines how the classification and labelling details for mixtures may be provided in Section 2 from 1st December 2010 until 1st June 2015:

 

Subsection 2.1 - Classification

  • Classification according to Directive 1999/45/EC. (If the mixture does not meet criteria for classification in accordance with Directive 1999/45/EC, this must be stated).
  • The most important adverse physical properties, human health and environmental effects, in a way so as to allow non-experts to identify the hazards of the mixture.

 

Subsection 2.2 - Label elements

The following elements appearing on the label according to CPL must be provided:

  • Graphical reproduction of the symbol in black and white (or colour)
  • Indication(s) of danger
  • Risk phrase(s) and safety advice

 

Subsection 2.3 - Other Hazards

Details to be provided on hazards which do not result in classification but may contribute to the overall hazard of the mixture.

An example of how the classification and labelling details may be laid out for mixtures within section 2 from 1st December 2010 to 1st June 2015 is as follows:

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Other requirements under the revised Annex II:

There are a number of changes in format and information requirements, for example:

  • Section 15 will no longer contain any classification details but will provide details on the regulatory information on the substance/mixture, details on any authorisations/restrictions and whether a Chemical Safety Report (CSR)/Chemical safety assessment (CSA) has been prepared.
  • Section 16 will include other information such as a list of relevant R phrases, hazard statements, safety phrases and/or precautionary statements and the full text of any statements which are not written out in full under Sections 2 to 15.

All of the requirements can be found at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:133:0001:0043:EN:PDF

 

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